The Federal Circuit in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. held that U.S. district courts have specific jurisdiction over an ANDA filer in any state they intend to market.1
The court reviewed two interlocutory appeals from separate rulings by the U.S. District Court for the District of Delaware regarding Mylan’s Rule 12(b)(6) motion to dismiss for lack of personal jurisdiction. Mylan filed Abbreviated New Drug Applications (ANDAs) for Ampyra®, Onglyza® and Kombiglyze™, submitting with each a paragraph IV certification – stating that the Orange Book listed patents covering the drugs were invalid or would not be infringed by Mylan’s marketing of its proposed drug.
As a paragraph IV certification constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A), both Acorda and AstraZeneca sued Mylan for infringement in the District of Delaware.2 Both Judges Stark and Sleet ruled that Delaware does have specific personal jurisdiction over the respective case; however; the judges ruled separately on the matter of general personal jurisdiction. Judge Stark ruled that Delaware had general personal jurisdiction while Judge Sleet ruled that they did not. Specific jurisdiction arises from the result of a specific incident while general jurisdiction arises when a court has jurisdiction over a defendant regardless of the type of claim.
The Federal Circuit granted both appeals and ruled only on the specific personal jurisdiction question. Although the court had the opportunity to address the question of whether Delaware also has general personal jurisdiction over Mylan – by way of registering to do business in and appointing an agent to accept service in Delaware – it punted the question for a later case.
In deciding the specific personal jurisdiction issue, the court looked to the ‘minimum contacts requirement’ set out by the Supreme Court in 1945.3 Under this requirement, a court may exercise specific personal jurisdiction without violating the Due Process Clause when the defendant has certain minimum contacts with the forum and no traditional notions of fair play and substantial justice are offended.
The true issue remained how Mylan established minimum contacts when they had performed no marketing to date for their proposed ANDA drug. The court looked to Congress intention when enacting § 271(e)(2), noting that “Congress deemed the ANDA filing to have a non-speculative casual connection to the ANDA filer’s future infliction of real-world market injury on the patent holder.”4
The court looked to multiple factors in deciding that Mylan “undisputedly” intended to market in Delaware. The court put most emphasis on the ‘economic realities’ – i.e. massive costs, estimated between $250,000 to $25 million – of getting an ANDA granted coupled with Mylan’s extensive market presence and sales throughout the U.S. The court also noted that Mylan is registered to do business in Delaware and with the Delaware Board of Pharmacy as well as having an appointed agent to receive service of process. The court noted, however, that even if Mylan did not intend to directly market the ANDA drug in Delaware, it would direct its wholesalers and distributers to do so thereby meeting the minimum contacts requirement.